TORONTO, ON — June 4, 2002 —
Lorus Therapeutics Inc. (“Lorus”) announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for Virulizin in the treatment of pancreatic cancer.
Virulizin® is the company’s most advanced drug in clinical development, currently being studied in a North American Phase III clinical trial.
The Fast Track designation means that the FDA will take actions to facilitate the development and expedite the review of Virulizin.
Drug designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast Track products usually meet the FDA’s criteria for priority review.
“Clearly the FDA recognizes the devastating effects of pancreatic cancer and the urgent need for new therapies to treat patients with this disease,” said Dr. Jim Wright, chief executive officer, Lorus.
“This regulatory achievement is further confirmation of the potential of Virulizin as an effective anticancer drug, and we are working hard to progress our Phase III clinical trial program to the New Drug Application stage.
” Virulizin is a potent and unique immunotherapy that directly stimulates macrophages and enhances their ability to kill tumor cells. Virulizin is being studied as a first line therapy in combination with gemcitabine for the treatment of pancreatic cancer. The Phase III clinical trial of Virulizin is a double-blind, randomized clinical trial being conducted at medical centers around North America enrolling 350 patients with advanced (unresectable, recurrent or metastatic) pancreatic cancer.
Patients are randomized to receive either treatment with gemcitabine or treatment with gemcitabine in combination with Virulizin. Those patients who fail or become refractory to gemcitabine are treated with 5-Fluorouracil (5-FU) or with 5-FU in combination with Virulizin in a second line therapy.
All study subjects will be monitored throughout the remainder of their lifespan. Virulizin has already been awarded Orphan Drug Status from the FDA in 2001. It also is approved in Mexico for the treatment of malignant melanoma.
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